HIV Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-06-18FDA Approved: YEZTUGO — Original Application (Gilead Sciences, Inc.)
The FDA approved YEZTUGO (lenacapavir sodium) via an original application for the treatment of HIV-1 infection in adults with limited treatm…
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EMA approval · 2025-06-18EMA Authorised: Atazanavir Viatris (previously Atazanavir Mylan) (atazanavir (as sulfate)) — Viatris Limited
EMA authorised Atazanavir Viatris (atazanavir sulfate) for HIV infections; Viatris Limited is the marketing authorization holder.
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FDA approval · 2025-06-12FDA Approved: DELSTRIGO — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for DELSTRIGO, Merck's fixed-dose combination HIV-1 therapy (doravirine/lamivudine/tenofovir disopro…
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FDA approval · 2025-06-12FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Cipla USA Inc.)
FDA approved Cipla USA Inc.'s supplemental application for a generic fixed-dose combination of emtricitabine and tenofovir disoproxil fumara…
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FDA approval · 2025-05-20FDA Approved: EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approves a generic fixed-dose combination tablet containing emtricitabine, rilpivirine, and tenofovir disoproxil fumarate for treatment …
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FDA approval · 2025-05-13FDA Approved: MARAVIROC — Original Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved an original ANDA for Maraviroc submitted by Zydus Pharmaceuticals USA Inc., authorizing a generic version of the HIV-1 entr…
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FDA approval · 2025-05-12FDA Approved: EVOTAZ — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for EVOTAZ (atazanavir and cobicistat) from E.R. Squibb & Sons, L.L.C., indicating a modification to…
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FDA approval · 2025-05-08FDA Approved: LAMIVUDINE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for lamivudine submitted by Camber Pharmaceuticals, expanding the approved product to lamivudine…
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FDA approval · 2025-05-08FDA Approved: ATAZANAVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals' generic atazanavir. Atazanavir is used in the treatment of HIV infection…
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FDA approval · 2025-04-22FDA Approved: FOSAMPRENAVIR CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for fosamprenavir calcium from Sun Pharmaceutical Industries, Inc., updating the approval under the …
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FDA approval · 2025-04-21FDA Approved: ZIDOVUDINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Zidovudine submitted by Aurobindo Pharma Limited.
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FDA approval · 2025-04-16FDA Approved: ABACAVIR AND LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' Abacavir and Lamivudine as an original application for the treatment of HIV-1 infection.
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FDA approval · 2025-04-11FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for CABENUVA (cabotegravir and rilpivirine) submitted by ViiV Healthcare Company.
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FDA approval · 2025-04-11FDA Approved: VOCABRIA — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for VOCABRIA (cabotegravir sodium) from ViiV Healthcare Company, updating the product labeling.
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FDA approval · 2025-03-21FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for PREZCOBIX (darunavir ethanolate and cobicistat) from Janssen Products, LP, expanding its lab…
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EMA approval · 2025-03-19EMA Authorised: Tenofovir disoproxil Zentiva (tenofovir disoproxil phosphate) — Zentiva k.s.
The European Medicines Agency authorised Tenofovir disoproxil Zentiva for HIV infections; the active substance is tenofovir disoproxil phosp…
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EMA approval · 2025-03-18EMA Authorised: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (efavirenz;emtricitabine;tenofovir disoproxil phosphate) — Zentiva k.s.
The EMA has authorised a fixed-dose combination antiretroviral therapy (efavirenz/emtricitabine/tenofovir disoproxil phosphate) by Zentiva f…
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EMA approval · 2025-02-19EMA Authorised: Apretude (cabotegravir) — ViiV Healthcare B.V.
The EMA authorised Apretude (cabotegravir) by ViiV Healthcare B.V. for HIV infections, marking EU approval of this long-acting injectable th…
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FDA approval · 2025-02-19FDA Approved: ODEFSEY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for ODEFSEY from Gilead Sciences. ODEFSEY is the fixed-dose combination of emtricitabine, rilpivirin…
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EMA approval · 2025-02-05EMA Authorised: Emtricitabine/Tenofovir disoproxil Krka d.d. (emtricitabine;tenofovir disoproxil succinate) — KRKA, d.d., Novo mesto
The European Medicines Agency authorised a fixed-dose combination antiretroviral therapy of emtricitabine and tenofovir disoproxil succinate…
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EMA approval · 2025-01-31EMA Authorised: Emtricitabine/Tenofovir disoproxil Krka (emtricitabine;tenofovir disoproxil succinate) — KRKA, d.d., Novo mesto
The EMA authorised the fixed-dose combination emtricitabine/tenofovir disoproxil for HIV infections, marketed by KRKA, d.d., Novo mesto.
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EMA approval · 2025-01-28EMA Authorised: Darunavir Krka (darunavir) — KRKA, d.d., Novo mesto
The EMA authorised Darunavir Krka for treatment of HIV infections.
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EMA approval · 2025-01-22EMA Authorised: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (efavirenz;emtricitabine;tenofovir disoproxil succinate) — KRKA, d.d., Novo mesto
The EMA authorised KRKA’s fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil succinate for HIV infections.
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FDA approval · 2025-01-21FDA Approved: DARUNAVIR — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application to market a generic version of darunavir for the treatment of HIV-1 infection. Thi…
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FDA approval · 2024-12-19FDA Approved: ABACAVIR AND LAMIVUDINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved a generic combination tablet of abacavir and lamivudine through an Original Application filed by Macleods Pharmaceuticals Limit…